Events

Recall of Device Recall Optovue iVue

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Optovue Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    56759
  • Event Risk Class
    Class 2
  • Event Number
    Z-1004-2011
  • Event Initiated Date
    2010-07-20
  • Event Date Posted
    2011-02-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-02-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94463
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, imaging, optical coherence tomography (oct) - Product Code NQQ
  • Reason
    Use of the cam attachment may result in a positioning anomaly and mistreatment in the eyes of the patient.
  • Action
    Optovue Inc. sent a Field Modification/Correction Notice dated July 20, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were informed that they could continue to use the iVue until the correction has been made. Customers were instructed to review any existing iVue patient data to ensure that this situation and an improper designation of eye assignment has not occurred. Upon completion of the updates, customers were to sign the attached form indicating they acknowledge that their iVue has been updated and they understand that they must review existing data. For any questions regarding this recall call 1-866-344-8948 or by mail at 45531 Northport Loop W, Fremont, CA 94538.

Device

Device Recall Optovue iVue
  • Model / Serial
    Serial numbers: 20305, 20307, 20340, 20335, 20306, 20313, 20339, 20337, 20338, 20341, 20311, 20271, 20343, 20312, 20309, 20310, 20308, 20336, 20344, 20349, 20346, 20347
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Optovue iVue optical coherence tomography system, computer controlled opthalmic imaging system, manufactured by Optovue, Fremont, CA || Computer controlled opthalmic imaging system. Device scans the patient's eye using low coherence interferometer to measure the reflectivity of the retinal tissue. The cross sectional retinal tissue structure is composed of a sequence of A-scans. It has a traditional patient and instrument interface. The computer has a graphic user interface for acquiring and analyzing the image. The iVue offers three scans: Retina, Glaucoma and Cornea. For the cornea scan, a lens must be attached to the front of the device for proper scanning. This is the Cornea Anterior Module (CAM).
  • Manufacturer
    Optovue Inc.

Manufacturer

Optovue Inc.
  • Manufacturer Address
    Optovue Inc., 45531 Northport Loop W, Fremont CA 94538-6417
  • Manufacturer Parent Company (2017)
    Optovue Inc.
  • Source
    USFDA